PMID- 29656600
OWN - NLM
STAT- MEDLINE
DCOM- 20190418
LR  - 20221207
IS  - 1542-4758 (Electronic)
IS  - 1492-7535 (Linking)
VI  - 22
IP  - 4
DP  - 2018 Oct
TI  - Long-term efficacy and safety of sucroferric oxyhydroxide in African American 
      dialysis patients.
PG  - 480-491
LID - 10.1111/hdi.12663 [doi]
AB  - INTRODUCTION: Sucroferric oxyhydroxide (SFOH) is a non-calcium, iron-based 
      phosphate binder that demonstrated sustained serum phosphorus (sP) control, good 
      tolerability, and lower pill burden, vs. sevelamer carbonate ("sevelamer"), in a 
      Phase 3 study conducted in dialysis patients with hyperphosphatemia. This 
      analysis evaluates the efficacy and safety of SFOH and sevelamer among African 
      American (AA) patients participating in the trial. METHODS: Post hoc analysis of 
      a 24-week, Phase 3, open-label trial (NCT01324128) and its 28-week extension 
      study (NCT01464190). Patients were randomized 2:1 to SFOH (1.0-3.0 g/day) or 
      sevelamer (2.4-14.4 g/day) for up to 52 weeks. FINDINGS: Of 549 patients who 
      completed the Phase 3 study and extension, 100 (18.2%) AA patients were eligible 
      for efficacy analysis (SFOH, n = 48; sevelamer, n = 52). sP concentrations 
      decreased rapidly and comparably with both treatments by Week 8 (mean +/- standard 
      deviation change from baseline: -1.9 +/- 1.9 mg/dL for SFOH and -2.2 +/- 1.8 mg/dL 
      for sevelamer). These reductions were maintained for 52 weeks (-2.1 +/- 2.6 and 
      -2.1 +/- 1.6 mg/dL) and achieved with a lower mean pill burden (3.4 +/- 1.4 vs. 
      7.6 +/- 2.9 tablets/day) with SFOH vs. sevelamer. Treatment adherence rates 
      (adherence within 70%-120% of expected medication intake) were 79.2% with SFOH 
      and 59.6% with sevelamer. The proportion of patients reporting serious adverse 
      events (AEs) was 27.7% with SFOH and 30.7% with sevelamer. More patients withdrew 
      due to treatment-emergent AEs with SFOH vs. sevelamer (18.5% vs. 8.0%). The most 
      common AEs with both treatments were gastrointestinal-related: diarrhea and 
      discolored feces with SFOH, and nausea, vomiting, and constipation with 
      sevelamer. DISCUSSION: SFOH is an efficacious and well-tolerated treatment for 
      hyperphosphatemia in AA dialysis patients, with a lower pill burden and an 
      improved adherence rate vs. sevelamer. These findings were consistent with the 
      wider US patient population and the overall study population.
CI  - (c) 2018 The Authors Hemodialysis International published by Wiley Periodicals, 
      Inc. on behalf of International Society for Hemodialysis.
FAU - Sprague, Stuart M
AU  - Sprague SM
AD  - NorthShore University HealthSystem, Chicago, Illinois, USA.
FAU - Ketteler, Markus
AU  - Ketteler M
AD  - Coburg Clinic and KfH-Dialysis Center, Coburg, Germany.
FAU - Covic, Adrian C
AU  - Covic AC
AD  - 'Gr.T. Popa' University of Medicine and Pharmacy, Iasi, Romania.
FAU - Floege, Jurgen
AU  - Floege J
AD  - RWTH University Hospital Aachen, Aachen, Germany.
FAU - Rakov, Viatcheslav
AU  - Rakov V
AD  - Vifor Pharma, Glattbrugg, Switzerland.
FAU - Walpen, Sebastian
AU  - Walpen S
AD  - Vifor Pharma, Glattbrugg, Switzerland.
FAU - Rastogi, Anjay
AU  - Rastogi A
AD  - University of California, Los Angeles, California, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01324128
SI  - ClinicalTrials.gov/NCT01464190
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180415
PL  - Canada
TA  - Hemodial Int
JT  - Hemodialysis international. International Symposium on Home Hemodialysis
JID - 101093910
RN  - 0 (Drug Combinations)
RN  - 0 (Ferric Compounds)
RN  - 0 (sucroferric oxyhydroxide)
RN  - 57-50-1 (Sucrose)
SB  - IM
MH  - Black or African American
MH  - Drug Combinations
MH  - Female
MH  - Ferric Compounds/pharmacology/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Renal Dialysis/*methods
MH  - Sucrose/pharmacology/*therapeutic use
OTO - NOTNLM
OT  - Phosphate binder
OT  - chronic kidney disease
OT  - hemodialysis
OT  - hyperphosphatemia
OT  - sucroferric oxyhydroxide
EDAT- 2018/04/16 06:00
MHDA- 2019/04/19 06:00
CRDT- 2018/04/16 06:00
PHST- 2017/11/27 00:00 [received]
PHST- 2018/02/21 00:00 [revised]
PHST- 2018/04/16 06:00 [pubmed]
PHST- 2019/04/19 06:00 [medline]
PHST- 2018/04/16 06:00 [entrez]
AID - 10.1111/hdi.12663 [doi]
PST - ppublish
SO  - Hemodial Int. 2018 Oct;22(4):480-491. doi: 10.1111/hdi.12663. Epub 2018 Apr 15.